Stool Softener Laxative

Product NDC
63941-855
11-digit product format
639410855
Labeler code
63941
Product ID
63941-855_6b72494e-bc45-48ed-8e56-213796ae7e4b
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
Best Choice (Valu Merchandisers Company)
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-01
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50; 8.6 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Stool Softener Laxative
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 mg/1
SENNOSIDES8.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup
3FYP5M0IJXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998740Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4bcf2ea2-7de2-4b89-b7b4-e132457f8a81Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63941-855-10Stool Softener Laxative1 in 1 BOXTABLET15
63941-855-10Stool Softener Laxative100 in 1 BOTTLE, PLASTICTABLET1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-855STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [BEST CHOICE (VALU MERCHANDISERS COMPANY)]5Current NDC, Legacy NDC, 2 package rows20240906_4bcf2ea2-7de2-4b89-b7b4-e132457f8a81.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESBest Choice (Valu Merchandisers Company)4bcf2ea2-7de2-4b89-b7b4-e132457f8a812024-09-04WarningsExact identifier
ndc (product): 63941-855

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN4bcf2ea2-7de2-4b89-b7b4-e132457f8a815
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD4bcf2ea2-7de2-4b89-b7b4-e132457f8a815
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY4bcf2ea2-7de2-4b89-b7b4-e132457f8a815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63941-855-10639410855101 BOTTLE, PLASTIC in 1 BOX (63941-855-10) / 100 TABLET in 1 BOTTLE, PLASTIC2020-08-010000-00-00NoNoCurrent